Endoscopic tissue stabilization device and related methods of use

ABSTRACT

Embodiments of the invention include a sleeve for use in a body lumen defined by body tissue. The sleeve includes a collapsible wall defining a lumen and including an inflatable member configured to increase a volume of the lumen when the inflatable member is in an inflated state, a conduit configured to inflate the inflatable member, and a port defined by the collapsible wall and in flow communication with the lumen.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/339,910, filed on Dec. 29, 2011, which is a continuation of U.S.application Ser. No. 11/058,167, filed on Feb. 16, 2005, now U.S. Pat.No. 8,088,139, which claims priority to provisional U.S. Application No.60/544,350, filed Feb. 17, 2004, all of which are incorporated herein byreference in their entirety.

DESCRIPTION OF THE INVENTION

1. Field of the Invention

Embodiments of the invention include a sleeve for use in a body lumendefined by body tissue. The sleeve includes a collapsible wall defininga lumen and including an inflatable member configured to increase avolume of the lumen when the inflatable member is in an inflated state,a conduit configured to inflate the inflatable member, and a portdefined by the collapsible wall and in flow communication with thelumen.

2. Background of the Invention

Endoscopic methods are commonly used for diagnosis and/or treatment ofthe gastrointestinal tract. For example, there are several methods oftreating esophageal cancer known as endoscopic mucosal resection.Endoscopic mucosal resection may include snaring and then excisingsessile adenomas (i.e., tumors attached to a bodily surface) in theesophageal tract. If the adenoma is flat against the esophageal tract,thus making it difficult to snare and excise, one of several methods maybe used to raise the flat adenoma so that it may be snared and excised.One method includes using forceps to raise the flat adenoma. Anothermethod includes using a vacuum to raise the flat adenoma. A furthermethod includes injecting saline into the submucosa so as to raise theflat adenoma. If, during saline injection, it is determined that theadenoma is attached to multiple esophageal layers, additional methodsmay be required to remove the adenoma.

The aforementioned methods and other endoscopic methods requiring accessto tissue within the gastrointestinal tract, while effective, havecertain drawbacks. For example, due to the tissue folds and constrictedspace in some portions of the gastrointestinal tract, including theesophagus, it may be difficult to identify, stabilize, access, and/orexcise tissue even with the use of an endoscope, especially if tissuesuch as an adenoma is attached to multiple esophageal layers.

SUMMARY OF THE INVENTION

In accordance with the invention, an embodiment includes a sleeve foruse in a body lumen defined by body tissue. The sleeve includes acollapsible wall defining a lumen and including an inflatable memberconfigured to increase a volume of the lumen when the inflatable memberis in an inflated state, a conduit configured to inflate the inflatablemember, and a port defined by the collapsible wall and in flowcommunication with the lumen.

Various embodiments of the invention may include any or all of thefollowing features. When the inflatable member is in the inflated state,the sleeve may be configured to substantially stabilize the body tissuedefining the body lumen. A non-inflating reinforcing member may beconfigured to support the collapsible wall. An embodiment may includealternating inflatable members and non-inflatable reinforcing members. Aplurality of non-inflating reinforcing members may be arrange about anaxis of the sleeve. The plurality of non-inflating reinforcing membersmay be spaced apart from each other. The collapsible wall may define anopen proximal end. The collapsible wall may define an open distal end. Asubstantially planar portion of the collapsible wall may define theport. A curved portion of the collapsible wall defines the port. Theinflatable member may include a plurality of longitudinal channelsinterconnected by at least one circumferential channel. The inflatablemember may include at least one circumferential channel. The inflatablemember may include at least one longitudinal channel. The inflatablemember may include a plurality of circumferential channelsinterconnected by at least one longitudinal channel.

Another embodiment of the invention includes a method of substantiallystabilizing body tissue defining a body lumen. The method includesproviding a sleeve including a collapsible wall defining a lumen andincluding an inflatable member configured to increase a volume of thelumen when the inflatable member is in an inflated state, the sleevefurther including a conduit configured to inflate the inflatable memberand a port defined by the collapsible wall and in flow communicationwith the lumen, advancing the sleeve into the body lumen in a collapsedconfiguration, and expanding the sleeve so as to exert pressure on andthereby substantially stabilize body tissue defining the body lumen.

Various embodiments of the invention may include any or all of thefollowing features. Expanding the sleeve may include providing fluid tothe inflatable member via the conduit. Orienting the sleeve in the bodylumen to position the port over a desired portion of body tissue.Advancing the sleeve may include advancing the sleeve through a workingchannel of an endoscope. The inflatable member may include a pluralityof longitudinal channels interconnected by at least one circumferentialchannel. The inflatable member may include at least one circumferentialchannel. The inflatable member may include at least one longitudinalchannel. The inflatable member may include a plurality ofcircumferential channels interconnected by at least one longitudinalchannel. The sleeve may includes a non-inflating reinforcing memberconfigured to support the collapsible wall. The sleeve may includealternating inflatable members and non-inflatable reinforcing members.The sleeve may include a plurality of non-inflating reinforcing membersarranged about an axis of the sleeve. The plurality of non-inflatingreinforcing members may be spaced apart from each other.

Additional objects and advantages of the invention will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Theobjects and advantages of the invention will be realized and attained bymeans of the elements and combinations particularly pointed out in theappended claims.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention andtogether with the description, serve to explain the principles of theinvention.

FIG. 1 is a perspective view of an endoscopic device according to anembodiment of the invention.

FIG. 2 is a perspective view of an endoscopic device according toanother embodiment of the invention.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to the exemplary embodiments of theinvention, examples of which are illustrated in the specification andaccompanying drawings. Wherever possible, the same reference numberswill be used throughout the specification and drawings to refer to thesame or like parts.

FIG. 1 depicts an exemplary embodiment of a sleeve. The sleeve 1 may beused with an endoscope and/or one or more endoscopic devices in amedical procedure such as endoscopic mucosal resection, or any othersuitable endoscopic or non-endoscopic procedure. The sleeve 1 mayinclude at least one wall 10, at least one inflatable member 20, atleast one port 30, and at least one conduit 40.

The at least one wall 10 may be configured to collapse and/or fold, forexample, when external pressure is exerted on the wall, in the absenceof supporting structures for the wall, and/or when inflatable members ofdevice 1 (to be described herein) are in an uninflated state. The sleeve1 will be in a collapsed, or contracted, state during its introductionto a tissue site. For example, sleeve 1 will be collapsed whenintroduced through a working channel of an endoscope. The wall 10 may bemade from a flexible polymer material or any other suitable,collapsible, and/or biocompatible material known in the art.

The wall 10 may be reinforced using any method or structure known in theart. For example, relatively rigid reinforcing members 11 made of anysuitable material (e.g., metal, polymer) may be disposed in the wall 10so as to support the wall 10. In FIG. 1, the reinforcing members 11 arecoaxial with the longitudinal axis 12 of the sleeve 1 so as to reduceand/or prevent the bending of the wall 10 and/or sleeve 1 in a desireddirection, for example, in the longitudinal direction. However, thereinforcing members 11 may be disposed in, or make up part of, any othersuitable orientation on the sleeve 1 and/or wall 10 that permits wall 10to collapse and expand, and may have any desired dimensions, so as toreduce and/or prevent the bending of the wall in any desired directionand/or amount. Thus, in the configuration depicted in FIG. 1, the wall10 would collapse between the reinforcing members 11.

The at least one inflatable member, or channel, 20 may be configured toinflate and/or become relatively rigid with the introduction ofmaterials (e.g., gas(es), and/or liquid(s)) into the inflatable member20. The inflatable member 20 may be made of substantially the samematerial as the wall 10, or may be made from a different suitablematerial. In the uninflated state, the inflatable member 20 may beconfigured to collapse.

FIG. 1 depicts inflatable members 20 integrated with the wail 10. Someof the members 20A may be disposed around a central lumen 21 and/orlongitudinal axis 12 of sleeve 1, and substantially form circles intheir inflated state. In particular, sleeve 1 includes a substantiallycircular member 20A at each of a proximal most end and a distal most endof sleeve 1. Sleeve 1 also includes inflatable members 20A′ alongintermediate portions of sleeve 12 (i.e., non-proximal most andnon-distal most portions of sleeve 12). Members 20A′ have portionssimilar to substantially circular members 20A, however, members 20A′ maynot extend fully around the sleeve 12 so as to form a complete circle.Ends of member 20A′ may be integrated with other portions of members 20,for example, members 20B as will be described below.

Other members 20B may be parallel to the longitudinal axis 12 and/orreinforcing members 11 so as to expand the sleeve 1 in the longitudinaldirection and/or provide support for the sleeve 1. In the sleeve of FIG.1, members 20B alternate with reinforcing members 11 about thecircumference of sleeve 1. At least some of the inflatable members 20may be in flow communication with each other. For example, as shown inFIG. 1, the circular inflation members 20A and 20A′ may be in flowcommunication with the longitudinal inflation members 20B and thereby inflow communication with one another. However, the inflatable members 20may also be divided into one or more discrete inflation systems that arenot in flow communication with each other.

The inflatable members 20, or at least the material defining theinflatable members 20, may be discrete from the wall 10 and instead beconnected to the wall 10 using any method known in the art, for example,adhesives. The inflatable members 10 may also be disposed at anyorientation with respect to the wall, and may have any desired geometricconfiguration. When inflated, the inflatable members 20 may cause thewall 10 to substantially flatten and/or unfold (i.e., form asubstantially wrinkle-free surface).

The at least one conduit 40 may be connected to wall 10 and/orinflatable members 20. The conduit 40 may be made out of the samematerial as the wall 10 and/or inflatable members 20 as set forth above,or it may be made from a different material known in the art. Theconduit 40 may be flexible and/or collapsible and sufficiently long toextend from a tissue site within a gastrointestinal tract, throughtortuous anatomy, and external to the patient.

The conduit 40 may be in fluid communication with the inflatable members20 so as to supply materials (e.g., gas(es), and/or liquid(s)) from amaterials source to the interior of the inflatable members 20 and causethe inflatable members 20 to inflate. The conduit 40 may be directlyconnected to at least one of the inflatable members 20 and otherwise influid communication with all of the inflatable members 20. In FIG. 1,the conduit 40 is integrated with the wall 10 at the proximal end ofsleeve 1. The conduit 40 may be connected to the sleeve 1 using anyconnection known in the art. At its proximal end, the conduit 40 may beconnected to an actuator and a materials supply source configured tocontrol the flow of materials to and/or from the sleeve 1 so as tocontrol the inflation and/or deflation of the sleeve 1.

Wall 10 defines at least one port 30. In FIG. 1, the port 30 is disposedon a center portion of one side of the wall 10 of sleeve 1 and issubstantially disposed between at least two inflatable members 20A andat least two inflatable members 20B. However, the port 30 may bedisposed on other portions of sleeve 1 and may have a portion thattraverses an inflatable member 20.

The port 30 may have any desired shape, dimensions and/or configurationdepending on several factors, among them the desired tissue tract areato access and the size of the endoscopic devices that may be advanced toor through the port. For example, as shown in FIG. 1 the port 30 has asubstantially flat and/or planar configuration due to the substantiallyplanar portion of wall 10 defining port 30.

The port 30 may also be configured so as to allow an endoscopic tool todraw tissue from the gastrointestinal tract into the central lumen 12via the port 30, for example, using forceps or suction. Once the tissueis disposed in the central lumen 12, various endoscopic tools known inthe art may be used to perform therapy and/or diagnosis on the tissue.

The sleeve 1 and/or any of the aforementioned portions of the sleeve 1may have any desired shape, dimension and/or configuration dependent on,for example, its deployment location. For example, the sleeve 1 may becurved if the sleeve 1 is to be deployed in a portion of thegastrointestinal tract where a bend may be necessary. In anotherexample, the sleeve 1 may have a substantially D-shaped or ovalcross-section.

The distal end 2 of the sleeve 1 may be sealed, for example, to preventmaterials from entering the central lumen 12 via the distal end 2 of thesleeve 1. The proximal end 3 may also or alternatively be sealed, forexample, in conjunction with the endoscope. If both the proximal end 3and distal end 2 are sealed, the proximal end 3 may be connected to avacuum source and a vacuum may be generated in the central lumen 12 ofthe sleeve 1 so as to allow tissue from the gastrointestinal tract to bevacuumed into the central lumen 12 of the sleeve 1 via the port 30.

At least one endoscopic tool may be used in conjunction with the sleeve.For example, the endoscopic tool may include a forceps, a biopsy forcepsjaw, an aspirator, an irrigator, a scissors-like devices, a knife, acutter, an electrocautery device, a needle, a snare, a basket, and anyother endoscopic tool known in the art. The endoscopic tool may bedisposed in the central lumen 21 or may be disposed external to thesleeve. The endoscopic tool may be advanced through the same endoscopeand/or endoscope channel as the sleeve 1, or the endoscopic tool may beadvanced into the gastrointestinal tract independently of the sleeve 1.For example, the endoscopic tool may be exterior and/or cross-parallelto the endoscope. The central lumen 21 may include one or more toolguiding channels configured to guide the endoscopic tool to a desiredportion of the sleeve 1, for example, port 30 and/or tissue extendinginto the central lumen 21 via port 30. The tool guiding channels mayalso be configured to guide the endoscopic tool out of the sleeve 1, forexample, through port 30, the opening on the proximal end 3 of thesleeve 1, and/or the opening on the distal end 2 of the sleeve 1.

The endoscopic tool used in conjunction with the sleeve 1 may be acutter, such as a snare, configured to cut tissue, for example, from thewalls of the gastrointestinal tract. The tissue may be cut by extendingthe cutter to or through the port 30. The tissue may be cut by firstdrawing tissue into the central lumen 12 through the port and thencutting the tissue.

The sleeve 1 may include a pouch or other storage portion configured toretrieve and store tissue samples acquired, for example, using theaforementioned cutter. The pouch may be disposed on any portion of thesleeve 1. For example, the pouch may be on the wall 10 and/or inflatablemember 20, and may be disposed on an internal and/or external portion ofthe sleeve 1. The pouch may be integrated with portions of the sleeve 1,or the pouch may be manufactured separately from the sleeve 1 and thenattached to the sleeve 1, for example, using adhesives.

The sleeve 1 may include a portion for performing electrocautery, forexample, at least one cautery wire. The cautery wire may be disposed onan external portion of and/or embedded in one or more of the wall 10,inflatable member 20, and conduit 40 in any desired shape, orientation,and/or configuration. The cautery wire may be connected to an electricalpower source external to the patient through suitable leads or otherwires. The cautery wire may be configured to cauterize a portion of thetissue wall defining the gastrointestinal tract that the cautery wirecomes into contact with.

One or more portions of the sleeve 1 may have a desired drug coating.For example, external portions of the wall 10 may be coated with a drugso that the wall 10, for example when inflated, may deliver drugs to aportion of the tissue defining the gastrointestinal tract. Alternativelyor in combination with a drug coating, sleeve 1 may include a coating ofany other desired therapeutic or diagnostic agent.

The sleeve 1 may have one or more conduits, in addition to conduit 40,connected to sleeve 1 and extending proximally to the exterior of thepatient. The conduit may be disposed within the central lumen 12, walls10, and/or inflatable members 20. The conduit may be disposed externalto the sleeve 1. The conduit may be configured to deliver materials(e.g., gas(es), and/or liquid(s)) to one or more portions of the sleeve1 and/or portions of the gastrointestinal tract so as to flush the oneor more portions of the sleeve 1 and/or portions of the gastrointestinaltract. The conduit may be configured to remove materials (e.g., gas(es),and/or liquid(s)) from one or more portions of the sleeve 1 and/orportions of the gastrointestinal tract.

FIG. 2 shows another embodiment of a sleeve 101 according to theinvention. The configuration of the sleeve 101 in FIG. 2 issubstantially similar to the configuration of the sleeve 1 in FIG. 1,except for the following differences. As shown in FIG. 2, the port 130may have a rounded and/or curved configuration due to the substantiallyrounded or curved portion of wall 110 defining port 130. The sleeve 101may also have inflation channels 120A′ running substantially adjacent tothe proximal and distal edges of the port 130, for example, to addrigidity to the port 130. Various inflation channels 120A′ may combineto form an inflation channel similar to inflations channels 120A, with adifference being that the inflation channels 120A′ are on anintermediate portion of the sleeve 101. Ends of the inflation channels120A′ adjacent the port 130 may be integrated with inflation channels120B. The inflation channels 120, 120A, 120A′, 120B may be in flowcommunication with at least one conduit 140.

Embodiments of the invention include methods of using a sleeve includingany or all of the aspects set forth above. For example, the method mayinclude providing the sleeve 1 in a collapsed configuration (i.e., thewalls 10 and/or inflatable members 20 are collapsed and not inflated),and then advancing the sleeve 1 into the gastrointestinal tract usingany method known in the art. In some embodiments, the sleeve 1 may beadvanced through a working channel of an endoscope, however, in otherembodiments the sleeve 1 may be advanced into the gastrointestinal tractindependently of an endoscope. The reinforcing members 11 may providesufficient structural support to sleeve 1 to prevent the sleeve 1 fromknotting, tangling, and/or twisting to a degree that does not permit thewall 10 and inflatable members 20 to properly inflate once it ispositioned in the desired portion of the gastrointestinal tract.

When the sleeve 1 has been advanced to the desired portion of thegastrointestinal tract, for example, the portion of the gastrointestinaltract having an adenoma, the sleeve 1 may be positioned so that the port30 is adjacent the portion of the gastrointestinal tract where therapyor diagnosis is desired. Proper positioning may be achieved through anysuitable imaging method, including use of the optics of an endoscope.

Materials (e.g., gas(es), and/or liquid(s)) from a materials source maythen be advanced through conduit 40 into at least one inflatable member20 so as to inflate the at least one inflatable member 20. As theinflatable member 20 inflates, the volume of the central lumen 21 of thesleeve 1 expands due to the uncollapsing, expansion, and/orstraightening of the wall 10. As the sleeve 1 expands, the walls 10and/or inflatable members 20 come into contact with, and exert pressureon, the walls of gastrointestinal tract and cause it to expand. Duringthis expanding of the walls of the gastrointestinal tract, the volume ofthe desired portion of the gastrointestinal tract is increased, thefolds of the tract walls are smoothed out, and/or the desired portion ofthe gastrointestinal tract is visible, stabilized, accessible, and/orenters the central lumen 21 through the port 30. Once inflated, thesleeve 1 forms a substantially rigid structure within thegastrointestinal tract. During or after inflation of the sleeve 1, theposition of the port 30 may be adjusted as desired. For example, ifinitial positioning does not permit access to the desired tissue, sleeve1 can be fully or partially uninflated and repositioned. Once the port30 is properly positioned, the port 30 may be used to permit access tothe desired portion of the gastrointestinal tract for therapy and/ordiagnosis.

Various types of therapy may be conducted on the desired tissue portionof the gastrointestinal tract via the walls 10, port 30, open distal end2, and/or open proximal end 3, some exemplary embodiments of which areset forth below.

If the distal end 2 and the proximal end 3 of the sleeve 1 are sealed,the port 30 may be placed substantially flush with the desired tissueportion of the gastrointestinal tract, and then a vacuum sourceconnected to the central lumen 21 of the sleeve 1 may be activated. Onceactivated, the desired tissue portion may be aspirated into the centrallumen 21 through the port 30, and then therapy may be performed on thedesired tissue portion.

If the distal end 2 and the proximal end 3 of the sleeve 1 are notsealed, the port 30 may be placed substantially flush with the desiredtissue portion of the gastrointestinal tract, and then the desiredtissue portion may be drawn into the central lumen 21 via the port 30using a suitable medical device, for example forceps or a separatesuction device placed proximate port 30.

The desired tissue portion may be cut from the gastrointestinal tract.The desired tissue portion may be cut using a cutter known in the art,such as a snare or a biopsy forceps jaw. The cutter may be advancedthrough the central lumen 21 and to or out of the port 30. The cutter,or other endoscopic tool, may be advanced to or out of the port 30 (orother desired portion of sleeve 1) via a tool guiding channel. Once cut,the tissue portion may be disposed in the central lumen 21 and thenaspirated out of the sleeve 1 via a device connected to the centrallumen 21, for example, a vacuum device. In the alternative, the tissueportion may be placed in a pouch connected to and/or integrally formedwith, or separate from, the sleeve 1. As a further alternative, thetissue may be removed via the closed jaws of a biopsy forceps jawassembly.

The desired tissue portion, and other portions of the gastrointestinaltract, may be flushed and/or irrigated with materials (e.g., gas(es),and/or liquid(s)) so as to, for example, clear obstructions from thedesired tissue portion. The materials may be delivered via a conduitdisposed in the central lumen 21 of sleeve 1, via the central lumen 21itself, a conduit integrated with the sleeve 1, and/or a conduitdisposed external to the sleeve 1.

The desired tissue portion, and other portions of the gastrointestinaltract, may have materials removed so as to, for example, clearobstructions from the desired tissue portion. The materials may beremoved via a conduit disposed in the central lumen 21 of sleeve 1, viathe central lumen 21 itself, a conduit integrated with the sleeve 1,and/or a conduit disposed external to the sleeve 1. The conduit may beconnected to a suitable vacuum source known in the art.

If drugs or other therapeutic or diagnostic agents are coated on aportion of the sleeve 1, such as the walls 10, then the sleeve 1 may beused to deliver drugs or agents to the desired tissue portions of thegastrointestinal tract so as to conduct chemical therapy on the desiredtissue portions. The sleeve 1 may be configured to apply the drug oragent evenly over the desired tissue portion when the sleeve 1 issubstantially in its fully inflated configuration.

If cautery wires are embedded in the sleeve 1, the sleeve 1 may be usedto cauterize portions of the gastrointestinal tract, for example, byproviding electricity to the cautery wires. Electrocautery may beapplied, for example, after severing tissue from the tract.

Once the desired therapy has been completed, the sleeve 1 may bedeflated by removing materials from the inflatable member 20 via theconduit 40 or another opening using any method known in the art (e.g.,opening a valve, puncturing a hole, and/or creating a vacuum). Duringthe removal of the materials, the inflatable member 20 and/or wall 10may collapse, and then the sleeve 1 may be removed from thegastrointestinal tract using any method known in the art, such asretraction through the working channel of an endoscope.

The devices and methods set forth above may be used in any medical ornon-medical procedure. For example, while the devices and methods setforth above are disclosed as being used in treating the gastrointestinaltract, they may also be used to treat any body lumen or organ.

Any of the various aspects set forth in any of the embodiments may beused in conjunction with any other aspect set forth in any of theembodiments. For example, more than one sleeve 1 may be advanced intothe gastrointestinal tract. Moreover, aspects may be removed fromembodiments if desired.

The sleeve 1 may have any desired dimensions, orientation, and/orconfiguration, for example, dimensions, orientation, and/orconfiguration that correspond to a particular portion of thegastrointestinal tract.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

1-20. (canceled)
 21. A medical method, comprising: introducing a sleeveinto a body space; and inflating portions of the sleeve to at leastpartially engage a tissue wall, wherein the sleeve includes a walldefining a lumen, a port in flow communication with the lumen, and aplurality of non-inflating portions spaced about a circumference of thewall, each of the plurality of non-inflating portions having a dimensionalong a longitudinal axis of the sleeve that is greater than a dimensionabout the circumference of the sleeve.
 22. The method of claim 21,further comprising: introducing a tool through a channel of an endoscopeinto the lumen of the sleeve.
 23. The method of claim 21, furthercomprising: accessing tissue at the port to perform a procedure.
 24. Themethod of claim 21, wherein the port is defined by a non-inflatingportion of the wall.
 25. The method of claim 21, wherein the port isdefined by a planar portion of the wall.
 26. The method of claim 21,wherein at least one cautery wire is coupled to the sleeve.
 27. Themethod of claim 21, wherein the port is defined by a portion of the wallrecessed from at least one inflatable portion.
 28. The method of claim21, wherein the sleeve further includes a plurality of inflatableportions configured to expand to the same diameter.
 29. The method ofclaim 28, wherein at least one of the plurality of inflatable portionsis at a distal-most end of the sleeve, and at least one of thenon-inflating portions contacts the at least one of the plurality ofinflatable portions at the distal-most end of the sleeve.
 30. The methodof claim. 29, wherein the sleeve further includes a pouch.
 31. A medicalmethod, comprising: introducing a sleeve into a body space; andexpanding the sleeve to at least partially engage a tissue wall, whereinthe sleeve includes a wall defining a lumen and a port in flowcommunication with the lumen, wherein the port is defined by a planar,non-inflating portion of the wall.
 32. The method of claim 31, furthercomprising: introducing a tool through a channel of an endoscope intothe lumen of the sleeve.
 33. The method of claim 31, further comprising:accessing tissue at the port to perform a procedure.
 34. The method ofclaim 31, wherein at least an exterior portion of the sleeve is coatedwith a drug.
 35. The method of claim 31, wherein the sleeve furtherincludes a plurality of inflatable portions configured to expand to thesame diameter.
 36. The method of claim 35, wherein at least one of theplurality of inflating portion is adjacent to the planar, non-inflatingportion.
 37. A medical method, comprising: introducing a sleeve into abody space; expanding the sleeve to at least partially engage a tissuewall, wherein the sleeve includes a wall defining a lumen and a port inflow communication with the lumen; accessing tissue at the port toperform a procedure; applying suction to the lumen of the sleeve; andaspirating tissue into the lumen of the sleeve through the port.
 38. Themethod of claim 37, further comprising: introducing a tool through achannel of an endoscope into the lumen of the sleeve.
 39. The method ofclaim 38, further comprising: accessing the tissue in the lumen of thesleeve with the tool to perform a procedure.
 40. The method of claim 37,further including aspirating tissue through of a distal end of thesleeve via a suction device in flow communication with the lumen.